Phase 1/2 Safety and Feasibility of Gemcitabine in Combination With LDE-225 as Neoadjuvant Therapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma
The investigators propose treating 6-12 patients during the phase 1 portion and 40 patients
in the phase 2 stage.
Phase 1 Stage:
1. Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8 and 15 in combination with escalating
doses of LDE-225. After completion of neoadjuvant therapy if the patients are eligible for
resection this will be performed followed by combined chemotherapy and radiation and two
additional cycles of Gemcitabine 1000 mg/m2 in combination with LDE-225.
Phase 2 Stage: In the Phase 2 stage the patients will be randomized to receive gemcitabine
with or without the hedgehog inhibitor LDE225:
1. Arm A: Four cycles of gemcitabine 1000 mg/m2 on days 1, 8 and 15 in combination with
LDE-225 at the recommended phase 2 dose.
2. Arm B: Four cycles of gemcitabine 1000 mg/m2 on days 1, 8 and 15.
After completion of neoadjuvant therapy if the patients are eligible for resection this will
be performed followed by combined chemotherapy and radiation and two additional cycles of
the pre-surgical therapy.
Several correlative laboratory studies will be conducted during the course of this study.
They were designed around the goals of providing us with a better understanding of how the
stroma-tumor interaction and the intra-tumoral drug levels of gemcitabine are affected with
the use of LDE-225. Two additional biopsies are required to participate in this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 1/2 Safety and Feasibility of Gemcitabine in combination with LDE-225 as Neoadjuvant Therapy in Patients with Borderline Resectable Pancreatic Adenocarcinoma.
Primary objective for phase I component of the trial: • To find the maximal tolerated dose of the combination of gemcitabine and LDE225 as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma. Primary objective for phase II component of the trial: • To evaluate the resection rate of two preoperative chemotherapy regimens in patients with borderline resectable pancreatic adenocarcinoma.
2 years
Yes
Ana De Jesus-Acosta, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center JHMI
United States: Food and Drug Administration
J1130
NCT01431794
September 2011
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |